EP4260823A1

EP4260823A1 - Coupling device for coupling a rod to a bone anchoring element and method of manufacturing the same

Info

Publication number: EP4260823A1
Application number: EP22167711.5A
Authority: EP
Inventors: Timo Biedermann; Lutz Biedermann; Berthold Dannecker
Original assignee: Biedermann Technologies GmbH and Co KG
Current assignee: Biedermann Technologies GmbH and Co KG
Priority date: 2022-04-11
Filing date: 2022-04-11
Publication date: 2023-10-18
Anticipated expiration: 2042-04-11
Also published as: EP4260823B1; US20230320755A1; US12042182B2

Abstract

A coupling device for coupling a rod to a bone anchoring element is provided, the coupling device (4) including a receiving part (5) comprising a first end (5a) and a second end (5b), a central longitudinal axis (C) extending through the first end (5a) and the second end (5b), an accommodation space (51b, 51c) for accommodating a head (3) of the bone anchoring element (1) with an opening (52) at the second end (5b) and a recess (54) for receiving the rod (100) adjacent to the first end (5a) , the recess defining two free legs (55), and a pressure member (6) arranged at least partially in the accommodation space (51b, 51c) , the pressure member (6) being movable from at least a first position in which an inserted head (3) is pivotable in the accommodation space (51b, 51c) and a second position in which the pressure member (6) exerts pressure onto an inserted head (3) such that the head (3) is provisionally locked; wherein in the second position the pressure member (6) is configured to engage the receiving part (5) by a latching connection such that the pressure member (6) is at least temporarily prevented from moving to the first position.

Description

The invention relates to a coupling device for coupling a rod to a bone anchoring element and to a method of manufacturing the same. In particular, the invention relates to a coupling device that forms part of a polyaxial bone anchoring device.
Various types of polyaxial bone anchoring devices are known in the art. Usually, a polyaxial bone anchoring device includes a coupling device and a bone anchoring element with a head that is pivotably received in the coupling device and can be locked at a desired angle of the bone anchoring element relative to the coupling device. The coupling device also receives a rod that is configured to connect the polyaxial bone anchoring device to a further bone anchor. US 9,339,302 B2 , for example, describes such a polyaxial bone anchoring device. The document also describes a two-part locking member for a polyaxial bone anchoring device that is manufactured using an additive manufacturing method.
In US 9,254,150 B2 another polyaxial bone anchoring device is described that includes a receiving part with a seat for receiving a head of a bone anchoring element and a channel for receiving a rod to be connected to the bone anchoring element. The bone anchoring element is pivotable with respect to the receiving part and can be fixed at an angle by exerting pressure via a pressure element onto the head. The pressure element includes a spring element that engages a portion of the receiving part via a detent connection so that the pressure element can be held in a position that allows pivoting of the anchoring element.
It is the object of the invention to provide a coupling device for coupling a bone anchoring element to a rod, in particular in a polyaxial manner, which coupling device is improved and/or is an alternative compared to conventional coupling devices, and a method of manufacturing such a coupling device.
The object is solved by a coupling device according to claim 1 and by a method according to claim 14. Further developments are given in the dependent claims.
According to an aspect the coupling device for coupling a rod to a bone anchoring element includes a receiving part comprising a first end and a second end, a central longitudinal axis extending through the first end and the second end, an accommodation space for accommodating a head of the bone anchoring element with an opening at the second end and a recess for receiving the rod, the recess defining two free legs, and a pressure member arranged at least partially in the accommodation space. The pressure member is movable from at least a first position in which an inserted head is pivotable in the accommodation space and a second position in which the pressure member exerts pressure onto an inserted head such that the head is provisionally locked. In the second position the pressure member is configured to engage the receiving part by a latching connection such that the pressure member is at least temporarily prevented from moving to the first position.
When the pressure member is in the second position, the head can be provisionally locked without the interaction of a rod and/or a fixation member with the receiving part or the pressure element. Moreover, the head can remain in the provisionally locked configuration without use of an instrument. This allows to carry out adjustment steps in a convenient and time saving manner.
According to an aspect, the pressure member can be moved into the second position by engaging an actuating portion of the pressure member that protrudes above the first end of the receiving part. This may reduce the required lateral space for an instrument to engage the pressure member.
According to a further aspect, in the provisional locking position of the pressure member, the head may be prevented from pivoting by a first clamping force. In a final locking position of the pressure member, the head may be prevented from pivoting by a second clamping force greater than or equal to the first clamping force. The second clamping force can be achieved by using a tool or a locking member, for example a locking screw, that acts onto the pressure member, for example via an inserted rod.
According to a further aspect, the latching connection between the pressure member and the receiving part can be released. Thereby, the pressure member can be moved out of the second position to release the provisional locking of the head. The actuating portion, preferably the arms of the pressure member, may be flexible, in particular resilient. Preferably, the actuating portion may be axially flexible. Further preferably the actuating portion may be flexible in a direction transverse to the central axis. By exerting a force onto the actuating portion, preferably transverse to the axial direction, the actuating portion is bent and the pressure member moved out of the second position. Thus, the step of provisionally locking and releasing the head can be carried out several times. Due to the flexibility of the arms of the pressure member, tolerances in the dimensions of the parts may be balanced.
According to a still further aspect, the engagement of the pressure member with the receiving part in the second position produces a tactile feedback for the user. Thereby the achievement of the second position can be safely determined.
According to a still further aspect, the receiving part and the pressure member are interconnected parts which are movable relative to each other but are inseparable prior to using the coupling device and/or during use. In other words, under conditions of use prior or during surgery and in the implanted state, the receiving part and the locking member cannot be separated from each other without damaging or destroying the coupling device. Hence, the coupling device is free from separate fixation members that keep the receiving part and the pressure member together. The coupling device may therefore consist of less parts. In addition, the parts are safely secured together.
In a particular embodiment, the coupling device is configured to provide a bottom-loading polyaxial bone anchoring device which allows to insert the head of the bone anchoring element from the bottom end of the coupling device. Alternatively, the coupling device may be designed for a top-loading polyaxial bone anchoring device in which the bone anchoring element is inserted from the top end of the receiving part into the coupling device.
A polyaxial bone anchoring device according to embodiments comprises in addition to the coupling device a bone anchoring element having a head and a shank, preferably wherein the head has a spherically-shaped outer surface portion.
The coupling device may be made using an additive manufacturing method, more specifically, an additive layer manufacturing method. In such a method, the coupling device is built up by layer-wise deposition of a building material and solidifying or melting the material in each layer at the cross-section of the coupling device in the respective layer. A suitable method is, for example, selective laser sintering (SLS) or selective laser melting (SLM) in which the building material is a powder, such as a metal powder or a plastic powder, and a laser is used to melt the powder. Alternatively, an electron beam may be used. Also, other known methods of powder based three-dimensional printing in which layers of a powder material are deposited and solidified by applying a binder material at positions corresponding to the coupling device may be used. Still further additive manufacturing methods, for example, fused deposition modeling (FDM) may also be applied.
Hence, the receiving part and the pressure member may have complex shapes and/or may be interconnected in a manner that may be difficult or impossible to manufacture conventionally. Thereby, an improvement with regard to the strength of the parts and an improved transfer of forces may be achieved. Moreover, using an additive manufacturing method for manufacturing the coupling device may be more cost efficient than using a conventional manufacturing method.
In a particular embodiment, the receiving part and the pressure member can be built up as a monolithic unit. The receiving part and the pressure member may be separated after they have been manufactured with the additive manufacturing method. More specifically, the monolithic unit may comprise a holding portion that is configured to hold the monolithic unit with a tool to allow separation of the receiving part and the pressure member from the holding portion by cutting. This allows to precisely separate the receiving part and the pressure member at a position As a result of the separation, the receiving part and the pressure member form an integrated unit.
It shall be noted that the additive manufacturing method, in particular an additive layer manufacturing method, may influence the appearance of the coupling device. For example, the layers may be visible on the surface of the finished object, even if the integrated unit comprising the receiving part and the pressure member is post-treated, such as polished, etched, coated or otherwise treated. It may also be possible to identify traces of the laser or electron beam when inspecting the fabricated object. Hence, the additive manufacturing method, in particular the additive layer manufacturing method can be distinguished on the basis of finished object compared to a conventional subtractive manufacturing method. Alternatively or in addition, the use of an additive manufacturing method may be identified on the basis of the geometry of the manufactured coupling device, for example, if such a geometry is not suitable for conventional manufacturing.
Further features and advantages of the invention will become apparent from the description of embodiments by means of the accompanying drawings. In the drawings:

Fig. 1:: shows a perspective view of a polyaxial bone anchoring device with a coupling device according to a first embodiment.
Fig. 2:: shows an enlarged cross-sectional view of a portion of the polyaxial bone anchoring device of Fig. 1, the cross-section taken in a plane perpendicular to the rod axis of an inserted rod.
Fig. 3:: shows an exploded view of the polyaxial bone anchoring device of Figs. 1 and 2, wherein the pressure member is shown separated from the receiving part for illustration purposes only.
Fig. 4:: shows a perspective view from a top of the coupling device according to Figs. 1 to 3.
Fig. 5:: shows an enlarged view of a detail of Fig. 4.
Fig. 6:: shows a perspective view from a bottom of the coupling device of Figs. 1 to 5.
Fig. 7:: shows a top view of the coupling device of Figs. 1 to 6.
Fig. 8:: shows a cross-sectional view of the coupling device of Figs. 1 to 7, the cross-section taken along line A-A in Fig. 7.
Fig. 9:: shows a cross-sectional view of the coupling device of Figs. 1 to 7, the cross-section taken in a plane along line B-B in Fig. 7.
Fig. 10:: shows a cross-sectional view of step of manufacturing the coupling device according to Figs. 1 to 9, the cross-section taken in a plane extending through a center of the legs of the receiving part and including the central axis.
Fig. 11:: shows a cross-sectional view of the step of manufacturing shown in Fig. 10 with a cutting line indicating a step of cutting away a holding portion of the coupling device.
Fig. 12:: shows a cross-sectional view of a step of assembling the polyaxial bone anchoring device of Figs. 1 to 9 in which the head of the bone anchoring element is inserted through a lower opening of the receiving part.
Fig. 13:: is a side-view of the step of assembling the polyaxial bone anchoring device corresponding to Fig. 12.
Fig. 14:: is a cross-sectional view of a further step of assembling the polyaxial bone anchoring device of Figs. 1 to 9, in which the pressure member is in an insertion position and the head of the bone anchoring element is fully inserted into the pressure member.
Fig. 15:: is a side-view of the step corresponding to Fig. 14.
Fig. 16:: shows a cross-sectional view of the polyaxial bone anchoring device of Figs. 1 to 9 wherein the pressure member is in a pre-locking position in which the head of the bone anchoring element is prevented from removal through the lower opening but is still pivotable in the receiving part.
Fig. 17:: is a side-view of the polyaxial bone anchoring device corresponding to Fig. 16.
Fig. 18:: shows a cross-sectional view of the polyaxial bone anchoring device of Figs. 1 to 9 wherein the pressure member is in a position in which the head is provisionally locked.
Fig. 19:: is a side-view of the polyaxial bone anchoring device corresponding to Fig. 18.
Fig. 20:: shows a perspective view of a polyaxial bone anchoring device with a coupling device according to a second embodiment.
Fig. 21:: shows a cross-sectional view of the polyaxial bone anchoring device of Fig. 20, the cross-section taken in a plane extending through a center of the legs of the receiving part and including the central longitudinal axis of the receiving part.
Fig. 22:: shows a perspective view from a top of the coupling device of Figs. 20 and 21, wherein the pressure member is in an insertion position that permits insertion of the head of the bone anchoring element.
Fig. 23:: shows a cross-sectional view of the coupling device as shown in Fig. 22, the cross-section taken in a plane extending through a center of the legs and including the central longitudinal axis of the receiving part.
Fig. 24:: shows a perspective exploded view of the coupling device of Figs. 20 to 23, wherein the receiving part and the pressure member are separated for illustration purposes only.

A polyaxial bone anchoring device according to a first embodiment, which is generally shown in Figs. 1 to 3, includes a bone anchoring element 1 in the form of a screw member having a threaded shank 2 and a head 3. On its free end, the head 3 may have a recess 3a for engagement with a tool. The bone anchoring device further includes a coupling device 4 for connecting the bone anchoring element 1 to an elongate stabilization member, such as a rod 100. The coupling device 4 is comprised of an integrated unit including a receiving part 5 and a pressure member 6 that are inseparably interconnected with each other. In Fig. 3, the receiving part 5 and the pressure member 6 are shown as separate parts for illustration purposes only. For securing the rod 100 in the receiving part 5 and to exert pressure onto the pressure member 6, a locking element 7 in the form of, for example, a set screw which cooperates with the receiving part 5 may further be provided.
Referring further to Figs. 4 to 9, the receiving part 5 is a substantially cylindrical part, preferably a monolithic part, and has a first or top end 5a, a second or bottom end 5b and a passage 51 extending from the top end 5a towards the bottom end 5b, the passage 51 defining a longitudinal central axis C. The top end 5a forms the uppermost end of the receiving part in the final state when extensions have been removed as explained below. By the passage 51 an opening 52 at the bottom end 5b is defined, which has a width that is greater than a greatest width of the head 3, so that the head 3 of the bone anchoring element 1 is insertable through the opening 52. The passage 51 may have several sections with different widths and/or shapes, and is not limited to the exact shape shown in the figures. Adjacent to the opening 52, a narrowing section 51a is provided which narrows, for example conically, towards the bottom end 5b. The narrowing section 51a cooperates with a portion of the pressure member 6, such that a compressive force is exerted via the pressure member 6 onto an inserted head 3. A widened section 51b follows the narrowing section 51a in a direction towards the top end 5a. The widened section 51b forms part of an accommodation space configured to accommodate a portion of the pressure member 6 and the head 3. A portion of the pressure member 6 is configured to expand in the accommodation space to permit the head 3 to enter. Further, the passage 51 may have an intermediate section 51c that has a smaller width than the widened section 51b, and permits a portion of the pressure member 6 to slide therein in an axial direction. A threaded bore 53 with an internal thread configured to cooperate with the locking member 7 extends from the top end 5a in the direction of the bottom end 5b. Moreover, a substantially U-shaped recess 54 that starts from the top end 5a defines two free legs 55 that form a channel for receiving the rod 100. A longitudinal axis of the substantially U-shaped recess 54 is coaxial with or parallel to a longitudinal axis of the straight rod 100 when the rod is inserted. As can be seen in particular in Fig. 2 a shoulder 51f limits the accommodation space towards the top end 5a.
Two extensions 56 project from the legs 55 above the top end 5a, respectively. The extensions 56 may serve during surgery for guiding the rod and the fixation member to the coupling device. This may be particularly useful in minimally invasive surgery (MIS). In greater detail, the extensions 56 form extended portions of the legs 55 and may be monolithically formed with the legs 55, respectively, via weakened sections 56a that have a reduced radial thickness. An internal groove 56b provided at the axial position of the weakened section 56a may further facilitate breaking-off of the extensions 56 from the legs 55. Breaking-off may be accomplished, for example, after the polyaxial bone anchoring device has been finally locked with the rod 100 and the locking member 7 inserted. The extensions 56 have an inner diameter that matches the inner diameter of the coaxial bore of the receiving part 5 and the internal thread 53 continues from the legs 55 into the extensions 56. An outer diameter of the extensions 56 may be reduced compared to the outer diameter of the legs 55.
In a circumferential direction at the center of each of the legs 55 and the corresponding extension 56 a recess 57 is formed that defines an opening through which a portion of the pressure member 6 can extend. As can be seen in particular in Figs. 3 to 6, on the left side and the right side of each recess 57 first axial slits 57a extend into the extensions 56. To the left and to the right of the first axial slits 57a, second axial slits 57b extend into the extensions 56 that are somewhat longer than the first axial slits 57a such that flexible tongs 57c between the axial slits 57a, 57b are formed. A lower edge of the extensions 56 that lies between the first axial slits 57a forms a first abutment 57d for a portion of the pressure member 6. The first abutment 57d defines an an insertion position of the pressure member 6. A lower edge of the flexible tongs 57c forms a second abutment 57e for the pressure member 6 . The tongues 57c may have an inclined surface 57f that is configured to permit a portion of the pressure member 6 to slide along when the pressure member 6 is moved downwards to spread apart the tongues 57c. The second abutment 57e defines a pre-locking position of the pressure member 6. In addition, an axially extending groove 58 may be formed that extends from a free end of the extensions 56 up to the recess 57 and that may provide a guidance for an instrument that is configured to actuate the pressure member 6.
Next, the receiving part 5 comprises inside each of the legs 55 substantially at the center thereof in a circumferential direction a slot 59 that is shaped such that a portion of the pressure member can extend therethrough. The slot 59 may have a depth corresponding to an axial position below the internal thread of the bore 53 and a width greater than a width of the recess 57. In greater detail, the width of the slot 59 in the circumferential direction allows arms of the pressure member 6 to extend therein. On the other hand, the slot 59 is in communication with the accommodation space 51b, 51c of the receiving part 5 via four openings 510 through which a portion of the pressure member can extend into the slot 59 as can be seen, for example, in Figs. 3 and 7 to 9. Moreover, in the middle of each of the legs 55 in the circumferential direction a protrusion 500 is formed at the outer surface of the receiving part 5 that defines an outer wall portion limiting the slot 59. The protrusion 500 comprises an outer surface 501 and an inner surface 502 that may both be substantially cylindrical. The inner surface 502 comprises an engagement portion in the form of a rib-like inner protrusion 503 located axially approximately in the middle of the protrusion 500. The rib-like inner protrusion 503 has a lower side 503a that may be substantially perpendicular to the central axis C and an inclined upper side 503b the inclination of which is such that a portion of the pressure member can slide thereon when the pressure member is moved downward. By the inner protrusion 503 a latching portion is formed that allows the pressure member 6 to snap thereunder. As can be seen in particular in Fig. 2 and Fig. 9, the inner wall 502 of the protrusion 500 is divided by the rib-like inner protrusion 503 in an upper space 505 and a lower space 506. The upper space 505 serves for accommodating an engagement portion of the pressure member when the pressure member is in an insertion position. The lower space 506 serves for accommodating the engagement portion of the pressure member 6 when the pressure member 6 is in the provisional locking position or in the final locking position. An outer contour of the protrusion 500 may be substantially rectangular when seen in projection in a side view, for example in Fig. 13, with two vertically extending short sides 500a and an upper circumferentially extending long side 500b that connects the short sides 500a and a lower long side 500c that may be concavely shaped. By means of the concavely-shaped lower long side 500c of the protrusion 500, a portion of the slot 59 may be exposed to the outside.
Lastly, in the section 51c of the receiving part 5, a shallow cylindrical recess 511 as particularly visible in Fig. 3, is formed to receive a portion of the pressure member 6 that supports the rod. The transverse holes 510 that are arranged between the accommodation space 51b, 51c and the slot 59 are arranged at each side of this recess 511.
The pressure member 6, preferably a monolithic piece, is formed with the receiving part as an integrated unit. Fig. 3 shows the pressure member as a separate part for explanation of its features only. The pressure member 6 comprises a main body 60 having a first end or top end 6a and a second end or bottom end 6b. Adjacent to the top end 6a, there is a substantially cylindrical upper portion 61 with an outer diameter that permits the main body 60 to move in the axial direction in the section 51c of the accommodation space. At the top end 6a, a rod receiving recess 62 is formed that provides a rod support surface. The rod support surface may have a substantially V-shaped cross-section with a longitudinal axis extending substantially perpendicular to the cylinder axis of the upper portion 61. Such a cross-section of the rod support surface allows to selectively receive rods of different diameter. A depth of the rod receiving recess 62 may be smaller than a diameter of the rod 100 such that when the rod 100 rests on the rod support surface, the rod projects over the top end 6a of the main body 60 as shown, for example in Fig. 2. A lower portion 63 of the pressure member 6 following the cylindrical portion 61 has a tapered, preferably conical, outer surface. The lowermost region 63a of the lower portion 63 adjacent to the bottom end 6b is configured to cooperate with the narrowing section 51a of the receiving part 5. In the lower portion 63, a head receiving recess 64 is formed that extends from the bottom end 6b to a distance from a bottom 62a of the rod receiving recess 62. The head receiving recess 64 has a substantially hollow spherical shape with a radius of the sphere matching that of the head 3 and thus forms a seat for the head 3 to pivot. At around the region with the largest diameter a circumferential cut-out 64a may be provided that enlarges the head receiving recess 64. This may facilitate spreading of the head receiving recess 64 for inserting the head 3. In addition, in the lower portion 63 of the main body 60 of the pressure member 6 a plurality of axial slits 65 that are open towards the bottom end 6b are provided which render the lower portion 63 flexible. To obtain a certain degree of flexibility, the slits 65 may widen towards their closed end 65a. The axial extension of the slits 65 may reach up to the upper region of the cut-out 64a.
Furthermore, the main portion 60 of the pressure member 6 comprises a coaxial bore 66 for allowing access to the head 3, more particularly to the recess 3a of the head 3, with a tool.
On the left and on the right side of the rod receiving recess 62 of the main body 60 upstanding arms 67 are formed that project to the side and upwards from the main portion 60. The arms 67 are mirror-symmetrical to a plane extending through the central longitudinal axis C and the longitudinal axis of the rod receiving recess 62. In the following one of the arms 67 will be described in greater detail. Each arm 67 has two substantially L-shaped base portions 67a that are connected, preferably monolithically, via their short sides to the conical section 63 of the main portion 60. On their long sides, the base portions are connected by a yoke portion 67b. An outer and an inner surface of the base portion 67a and the yoke portion 67b may be cylindrical and the long sides may be formed as thin stripes in the radial direction. The size of the base portions 67a is such that the base portions 67a are configured to extend through the openings 510 of the receiving part 5 into the slot 59. In other words, the yoke portion 67b is fully arranged in the slot 59 and the base portions 67a are configured to move axially in the openings 510, respectively. In the middle of the yoke portion 67b in the circumferential direction an actuating portion 68 extends upwards. The actuating portion 68 has a circumferential width smaller than that of the yoke portion 67b such that it fits into the slot 59 and also can project out of the slot 59 into the recess 57. A connection section between the actuating portion 68 and the yoke portion 67b is narrowed by two lateral slits 68a. Generally, the arms 67 and more specifically the actuating portion 68 is flexible to some extent in the axial direction and in a direction transverse to the axial direction. As a result thereof, the actuating portion 68 can be slightly compressed towards the main portion 60 in the axial direction. In addition, the actuating portion 68 can be bent inwards in the radial direction. Preferably, the actuating portion 68 is resiliently compressible in the axial and/or radial direction and resumes its original position once the pressure is relieved.
An upper side 68b of the actuating portion which is provided on an outwardly extending rim is configured to abut against the first abutment 57d on the extensions 56 when the pressure member 6 is in the insertion position or against the second abutment 57e when the pressure member 6 is in the pre-locking position. Adjacent to the yoke 67b, the actuating portion 68 comprises an outwardly protruding rib-like engagement portion 69. The engagement portion 69 has a flat upper surface 69a and an inclined lower surface 69b the inclination of which may correspond to that of the inclined portion 503b of the inner protrusion 503 of the protrusion 500. The upper side 69a of the engagement portion 69 is configured to snap under the protrusion 503 of the receiving part 5. Moreover, after snapping under the protrusion 503, the upper side 69a of the engagement portion 69 is configured to abut against the lower side 503a of the projection 503 to provide a latching connection.
The pressure member 6 is arranged in the receiving part 5 such that the main portion 60 is located in the accommodation space, at least in the section 51c and the arms 67 extend into and inside the legs 55 of the receiving part. The upper rim of the actuating portion 68 with the end surface 68b extends out of the legs 55 into the recess 57 provided at the extensions 56. Specifically, the receiving part 5 and the pressure member 6 are interconnected parts which are movable relative to each other but are inseparable prior to using the coupling device and/or during use. In other words, under conditions of use prior or during surgery and in the implanted state, the receiving part 5 and the pressure member 6 cannot be separated from each other without damaging or destroying the coupling device.
The pressure member 6 is movable in the receiving part 5 in such a manner that it can assume several positions. An insertion position of the pressure member 6 in which the head 3 can be inserted, is defined in that the pressure member 6 abuts with the upper surface 68b of the actuating portion 68 against the first abutment 57d in the extension 56. Simultaneously, the main body 60 of the pressure member 6 is an upper portion of the section 51c of the passage 51 and the engagement portion 69 is located in the upper space 505 of the inner wall 502 of the protrusion 500. A pre-locking position is defined in that the pressure member 6 abuts with the upper surface 68a against the second abutment 57e in the extension 56. An inserted head is still pivotable but cannot be removed through the lower opening 52. It should be mentioned that in the pre-locking position the head may be held in the pressure member 6 by friction so that it can be pivoted only if a force is applied that overcomes the friction force. In a provisional locking position of the pressure member 6 relative to the receiving part 5, the engagement portion 69 is in the lower groove 506 and the upper surface 69a of the engagement portion 69 abuts against the lower surface 503a of the projection 503 of the receiving part 5. In this provisional locking position, the lower section 63a of the conical outer surface 63 of the pressure member 6 engages the conical inner surface portion 51a adjacent to the lower opening 52c of the receiving part 5 to such an extent that the head receiving recess 64 of the pressure member 6 is compressed such that the head 3 cannot pivot, i.e. is locked with a first force. A final locking position is defined in that the pressure member 6 has engaged the narrowing portion 51a of the receiving part to such an extent, that the head is locked with a second force greater than the first force. This can be achieved by tightening the locking member 7.
The coupling device and parts thereof as well as the bone anchoring element and the locking element and the rod may be made of any bio-compatible material, preferably, however, of titanium or stainless steel or of any other bio-compatible metal or metal alloy or plastic material. As a bio-compatible alloy, a NiTi alloy, for example Nitinol, may be used. Other materials can also be magnesium or magnesium alloys. Bio-compatible plastic materials for use may be, for example, polyether ether ketone (PEEK) or poly-L-lactide acid (PLLA). The coupling device and other parts of the polyaxial bone anchoring device may be made of the same or of a different material.
Preferably, the coupling device is manufactured using an additive manufacturing method. In an additive manufacturing method, the coupling device is built up layer-by-layer based on three-dimensional data that characterize the shape and the size of the coupling device. As an example, a powder bed based layer manufacturing technique, such as selective laser-melting (SLM), includes the steps of applying a layer of building material, such as a powder, in particular a metal powder or a plastic powder, onto a support surface, and selectively solidifying or melding the powder at positions corresponding to the cross-section of the coupling device in the respective layer. Subsequently, the steps of applying and melting further layers of the coupling device are repeated until a coupling device is finished. The data of the cross-section of the coupling device in the respective layer and the data for controlling the layer manufacturing apparatus result from CAD or CAM data of the coupling device and corresponding slice data. In particular undercuts and complex shapes can be built-up. In the present embodiment, the extension of the arms through the legs of the receiving part that would almost be impossible to manufacture in a conventional subtractive manufacturing method which would require to manufacture the parts in several sub-parts to realize the complex shape.
An embodiment of a method of manufacturing the coupling device will be described referring to Figs. 10 and 11. The receiving part 5 and the pressure member 6 are manufactured using such an additive layer manufacturing technique as a monolithic unit 80. The monolithic unit 80 comprises a holding portion 81 that is monolithically connected to the receiving part 5 and also to the pressure member 6. In the example shown, the holding portion 81 is a tube-shaped portion with an upper end 81a and a lower end 81b. The upper end 81a comprises an inner tube portion 82 that is monolithically connected to the second end 6b of the main portion 60 of the pressure member 6. At a small distance therefrom in the radial direction, an outer tube portion 83 is monolithically connected to the second end 5b of the receiving part 5. The contour of the narrowing portion 51a may be separated from the inner tube portion 82.
A predetermined cutting face CF is defined at the second end 5b of the receiving part 5 and extends inside the receiving part up to and along the second end 6b of the pressure member. The predetermined cutting face CF may be marked, for example through externally visible markings that are generated during the layer-wise build-up and/or internal structures that facilitate the cutting, for example a weakened area. When the monolithic unit 80 has been built-up, unmelted or unsolidified building material can be removed through the tube of the holding portion 81 or for example through the openings which connect the slot 59 with the inside of the receiving part or the outside.
Once separated, the integrated unit comprising the receiving part 5 and the pressure member 6, may be further treated, for example polished, sandblasted, etched or coated. However, in some applications no post-treatment is carried out since a rough surface that may result from the building process may be desirable.
Steps for assembling the polyaxial bone anchoring device of Figs. 1 to 3 will be described referring to Figs. 12 to 19. In a first step, as shown in Figs. 12 and 13, the pressure member is in a position, in which the main portion 60 of the pressure member 6 is in an upper region of the section 51b, 51c of the passage 51. In particular, the lower end 6b is within the accommodation space 51b so that it can expand when the head 3 is inserted. The actuating portion 68 protrudes out of the recess 57 of the extension member 56 but does not yet abut against the abutment 57d of the extension member 56. When the bone anchoring element 1 is already inserted into bone, the receiving part 5 with pressure member 6 is placed onto the head 3 and the head 3 is introduced through the lower opening 52.
Next, as shown in Figs. 14 and 15, the head is inserted into the head receiving recess 64 of the pressure member 6. This is possible, since the head 3 widens the head receiving recess 64 while entering due to the flexibility of the conical portion 63. Thereby, the head 3 moves the pressure member 6 upwards until the end surface 68b of the actuating portion 68 abuts against the abutment 57d at the extension 56. This is the insertion position, in which the head 3 is fully inserted.
Subsequently, as shown in Figs. 16 and 17, the pressure member 6 with the inserted head 3 is moved downward by a force applied onto the actuating portion 68 in the axial direction (shown by vertical arrows) such that the lowermost portion 63a of the conical outer surface 63 of the main portion 60 of the pressure member 6 enters the conical portion 51a of the passage 51 to some extent. Thereby, the outer rim with the end surface 68a of the actuating portion 68 slides along the inclined surface 57f of the tongues and spreads the tongues 57c apart to let the actuating portion 68 pass until the end surface 68b abuts against the abutment 57e at the extension 56. In this position, the inclined surfaces 69b of the engagement portion 69 and 503b of the inner protrusion 503 of the receiving part 5 engage. Thereby, the pressure member 6 is held in the axial position. The lower opening 52 of the receiving part 5 is narrowed by the pressure member, so that removal of the head 3 is not possible in this pre-locking position but the head is still pivotable.
Finally, as shown in Figs. 18 and 19, the pressure member is moved further downward by a force applied onto the actuating portion 68 in the axial direction (shown by vertical arrows) until the engagement portion 69 of the arms snaps under the inner protrusion 503 of the receiving part so that the upper surface 69a engages the lower surface 503 a of the protrusion. A slight axial resiliency of the arms 67 assists in establishing the latching connection. The conical portion 63 of the pressure member 6 has further entered the narrowing section 51a of the passage 51 of the receiving part 5 so that the head 3 is provisionally locked. The provisional locking of the head 3 can be released by exerting a transverse force onto the actuating portion as shown by the transverse arrows in Fig. 18. Due to the flexibility of the arms 67, the actuating portion is bent slightly inwards and the engagement portion 69 moves out of engagement. Thereby the latching connection is released and the pressure onto the head 3 reduced so that it becomes pivotable again.
Finally, the pressure member 6 is pressed further into the narrowing section 51a of the passage 51, for example by inserting the rod 100 and the fixation member 7 and tightening the fixation member 7 as shown in Fig. 2 to finally lock the head in the coupling member. Thereafter, the extensions 56 may be broken-off at the weakened portions 56a.
In the clinical use, usually two polyaxial bone anchoring devices are connected through the rod 100. In a first way of use, the bone anchoring element 1 is first inserted into bone, for example, into the pedicle of a vertebra, and the coupling device 4 is mounted on the head 3 of the bone anchoring element 1 thereafter. In a second alternative way of use, the bone anchoring element 1 and the coupling device 4 are pre-assembled and inserted in the pre-assembled condition into the bone, for example, into pedicles of adjacent vertebrae. Prior to inserting the rod, the angular position of the coupling device relative to the bone anchoring element may be adjusted by provisionally locking and releasing the head in the coupling device a required number of times. For maintaining the provisional locking neither an instrument nor the rod together with the locking member are necessary.
Referring to Figs. 20 to 24, a second embodiment of the coupling device will be described. Parts and portions of the coupling device according to the second embodiment that are identical or highly similar to parts and portions of the coupling device of the first embodiment are indicated with the same reference numerals and the description thereof is not repeated. The coupling device 4' according to the second embodiment differs from the coupling device 4 of the first embodiment in the design of the receiving part and the pressure member. The rod 100 and the locking member 7 may be the same as in the first embodiment and are not shown.
The receiving part 5' in the second embodiment does not have extensions 56. Thus, the top end 5a forms the uppermost portion of the receiving part 5'. The narrowing section 51a of the passage 51 and the accommodation space 51b, 51c are highly similar to that of the first embodiment. Above the narrowing section 51c, a slot 59' is formed inside the legs 55'. The slot 59' extends between the outer wall of the receiving part 5' and the threaded bore 53. It narrows towards the top end 5a such that an opening or recess 57' is formed that has a width in the circumferential direction substantially adapted to the width of the actuating portion of the pressure member 6'. In the inner wall of the channel formed by the substantially U-shaped recess 54, at an axial position below the internal thread 53, a recess 58' is formed an upper edge of which serves as a first abutment 58a'. The first abutment 58a defines an uppermost position of the pressure member 6' as can be best seen in Fig. 23. Below the first abutment 58a', a second abutment 58b' is formed that defines a pre-locking position of the pressure member 6' in which an inserted head 3 is prevented from removal but still pivotable.
The slot 59' is connected to the inside of the passage 51 via an opening 510' through which a portion of arms of the pressure member 6' can extend. In addition, the receiving part 5' comprises at the middle of each of the legs 55' at a distance from the top end 5a a transverse hole 520 that extends from the outside into the slot 59'. A protrusion 500' is formed on the outer wall of the receiving part 5' through which the hole 520 extends. The protrusion 500' may serve as an orientation structure for facilitating engagement of the transverse hole 520 with an instrument. At an upper edge of the transverse hole 520 the inner wall of the slot 59 comprises a structure 521 that provides a lower surface 521a defining an abutment for a portion of the pressure member 6' and an inclined upper surface 521b along which the pressure member 6' can slide when it moves downward. At a lower edge of the transverse hole 520 another inclined surface 522 is formed that is configured to engage a correspondingly inclined surface of the pressure member 6'.
The pressure member 6' comprises a main portion 60' with a cylindrical upper section 61 with a rod receiving recess 62 and a substantially conical section 63 with the head receiving recess 64 as in the first embodiment. From the cylindrical portion 61 two sidewalls 600' extend on the left and on the right of the rod receiving recess 62. The sidewalls 600' may be flat towards the inside and may be cylindrical towards the outside to fit into the recesses 58' provided in the inner wall of the legs 55' of the receiving part 5'. The sidewalls 600' have a broadened rim 601' at their free end that is configured to abut against the first abutment 58a' of the recess 58' of the receiving part 5'. Moreover, the pressure member 6' comprises two arms 67' that extend from the cylindrical section 61 on the right and on the left of the rod receiving recess 62'. The arms 57' comprise a base 67a that is configured to extend through the opening 510'. From the base portion 67a' a main portion 67c' protrudes vertically that is substantially meander-shaped to provide some flexibility in the axial direction. The main portion 67c' may have a cylindrical inner and outer surface. At the uppermost end of the main portion 67c', a circumferential projection is provided that projects outwards and forms an engagement portion 69' for engagement with the receiving part 5'. An upper surface 69a' of the engagement portion 69' may be substantially perpendicular to the central axis C and is configured to engage the abutment 521a at the upper edge of the transverse hole 520. A lower surface 69b' is inclined and is configured to engage the inclined surfaces 521b and 522 at the upper and lower edge of the transverse hole 520. From the upper surface 69a' an actuating portion 68' protrudes that is configured to extend into the recesses 57' of the receiving part and to project above the top end 5a.
In use, the pressure member 6' is configured to assume several positions with respect to the receiving part 5'. The insertion position in which the head 3 is fully inserted into the head receiving recess 64 of the pressure member 6' is achieved when the upper surface 601' of the sidewalls 600' abuts against the first abutment 58a' of the recess 58' as shown in Fig. 23. The actuating portions 68' protrude above the top end 5a. The pre-locking position of the pressure member 6' is obtained when the inclined lower surface 69b' of the engagement portion 69' abuts against the second abutment 58b' of the receiving part 5'. The provisional locking position is achieved when the upper surface 69a' of the engagement portion 69' abuts against the lower surface 521a of the structure 521 at the upper edge of the transverse hole 520. The provisionally locking position can be reached by pressing the actuating portion 68' downward in an axial direction. By engaging the actuating portions 68' with a tool through the holes 520 and slightly pressing them towards the central axis, the provisional locking can be released. Final locking may be achieved by inserting the rod 100 and the locking member 7 as in the first embodiment.
It should be noted that for both embodiments described the insertion position and the pre-locking position may each be a first position of the pressure member in which the head is still pivotable. The provisional locking position may be a second position of the pressure member in which the head is provisionally locked.
Modifications of the above described embodiments are conceivable. In particular, the shape of the parts is not limited to the detailed shape shown in the figures. Deviations may be possible and encompassed by the disclosure. It shall be noted that the features of one embodiment can be also combined with features of the other embodiment. For example, the coupling device may be configured to for a top loading polyaxial bone anchoring device. Hence, the opening at the bottom end of the receiving part may be smaller than a diameter of the head of the bone anchoring element such that the bone anchoring element has to be inserted from the top end into the receiving part. In this case, the pressure member may be configured to press only from above onto an inserted head.
Instead of the locking member being a set screw all other kinds of locking assemblies known in the art may be used. For the bone anchoring element, all types of bone anchoring elements are suitable for anchoring in bone or a vertebra may be used, in particular also bone nails. The rod may have various shaped and/or varying cross-section along its length. The rod may be stiff or more flexible.

Claims

A coupling device for coupling a rod (100) to a bone anchoring element (1), the coupling device (4, 4') including
a receiving part (5,5') comprising a first end (5a) and a second end (5b), a central longitudinal axis (C) extending through the first end (5a) and the second end (5b), an accommodation space (51b, 51c) for accommodating a head (3) of the bone anchoring element (1) with an opening (52) at the second end (5b) and a recess (54) for receiving the rod (100) adjacent to the first end (5a) , the recess defining two free legs (55, 55'), and

a pressure member (6, 6') arranged at least partially in the accommodation space (51b, 51c) , the pressure member (6, 6') being movable from at least a first position in which an inserted head (3) is pivotable in the accommodation space (51b, 51c) and a second position in which the pressure member (6, 6') exerts pressure onto an inserted head (3) such that the head (3) is provisionally locked;

wherein in the second position the pressure member (6, 6') is configured to engage the receiving part (5, 5') by a latching connection such that the pressure member (6, 6') is at least temporarily prevented from moving to the first position.
The coupling device of claim 1, wherein the pressure member (6, 6') comprises a head contacting portion (64) configured to contact the head (3) when the pressure member (6, 6') is in the accommodation space (51b, 51c) and two arms (67, 67') extending away from the head contacting portion (64) and wherein each of the legs (55, 55') comprises a slot (59, 59') arranged between an outer wall (502) and an inner wall of the legs and wherein the arms (67, 67') extend into the slot (59, 59'), respectively.
The coupling device of claim 2, wherein the pressure member (6, 6') and the receiving part (5, 5') each comprise an engagement portion (69, 69'; 503, 521) and wherein the latching connection is established when the engagement portion (69, 69') of the pressure member (6, 6') snaps behind the engagement portion (503, 521) of the receiving part (5, 5') or vice versa, preferably wherein the engagement portion of the pressure member is located at the arms (67, 67') and the engagement portion of the receiving part is located at a sidewall (502) of the slot (59, 59').
The coupling device of claim 2 or 3, wherein a free end (68b, 68b') of the arms (67, 67') of the pressure member (6, 6') is exposed at or close to the first end (5a) of the receiving part (5, 5').
The coupling device of one of claims 2 to 4, wherein the pressure member (6, 6') is movable to the second position by exerting an axial force onto a free end (68b, 68b') of the arms (67, 67 ').
The coupling device of claim 5, wherein the arms (67, 67') are flexible, preferably in a direction transverse to the central axis, and wherein the latching connection is releasable by exerting a force onto the arms in a direction transverse to the central axis (C), preferably in a direction towards the central axis.
The coupling device of one of claims 1 to 6, wherein the pressure member (6, 6') is configured to return to the first position by releasing the latching connection.
The coupling device of one of claims 1 to 7, wherein the first position is an insertion position that allows the head (3) to be inserted through the opening (52) into the accommodation space (51b, 51c).
The coupling device of one of claims 1 to 7, wherein the first position is a pre-locking position in which the pressure member (6, 6') narrows the opening (52) to such an extent that an inserted head (3) is prevented from being removed from the accommodation space (51, 51a, 51b, 51c) through the opening (52) but is still pivotable.
The coupling device of one of claims 1 to 9, wherein in the first position the pressure member (6, 6') is configured to exert such a pressure onto an inserted head (3), that the head is prevented from pivoting without a rod or a fixation member or an instrument being required to maintain the pressure.
The coupling device of one of claims 1 to 10, wherein the receiving part (5) comprises extensions (56) that are provided at the legs (55), respectively, and wherein the extensions (56) each comprise an abutment (57d) for a portion of the pressure member (6), preferably for limiting an upward movement of the pressure member in the first position.
The coupling device of one of claims 1 to 10, wherein each of the legs (55') comprises a transverse opening (520), in an outer wall that limits the slot (59'), wherein the opening (520) permits access to exert a transverse force onto the portion of the pressure member (6') in the slot (59').
The coupling device of one of claims 1 to 12, wherein the receiving part (5, 5') and the pressure member (6, 6') are inseparably interconnected with each other, preferably wherein the receiving part (5, 5') and/or the pressure member (6,6') are monolithic parts, preferably wherein the coupling device is obtainable by an additive manufacturing method.
A method of manufacturing a coupling device of one of claims 1 to 13, wherein the method comprises an additive manufacturing method, preferably an additive layer manufacturing method, preferably a powder based method, more preferably wherein the additive layer manufacturing method is a method in which successive layers of a powder material are solidified or melted at positions corresponding to a cross-section of the coupling device in the respective layer by the action of energy, preferably by a laser beam or electron beam; the method including the step of
building the receiving part (5, 5') and the pressure member (6, 6') as an integrated unit.
The method of claim 14, wherein the integrated unit is formed as a monolithic unit, the method further comprising a step of separating the monolithic unit to obtain the receiving part (5, 5') and the locking member (6, 6'); the method preferably further including a step of forming the monolithic unit with a holding portion (80) for holding the monolithic unit for carrying out the separating step, preferably further including the step of separating the monolithic unit to obtain the integrated unit at at least one predefined position such that it is cut away from the holding portion (80).